A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

December 16, 2024 updated by: Boehringer Ingelheim

Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice

Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.

Study Overview

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Drug: Spiolto® Respimat®

Study Type

Observational

Enrollment (Actual)

4819

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Bulgaria
- - Dupnitza, Bulgaria, 2600
    - MBAL Sveti Ivan Rilski-2003
  - Gabrovo, Bulgaria, 5300
    - SBALBB "Pencho Semov" - Gabrovo EOOD
  - Haskovo, Bulgaria, 6300
    - SBALPFZ Haskovo EOOD
  - Karlovo, Bulgaria, 4300
    - MBAL Kiro Popov EOOD
  - Kozloduj, Bulgaria, 3320
    - MBAL Sv. Ivan Rilski EOOD
  - Lovech, Bulgaria, 5500
    - MBAL "Prof. Dr P. Stoyanov" AD - Mihail Kirov
  - Plovdiv, Bulgaria, 4002
    - Iliana Valkanova
  - Plovdiv, Bulgaria, 4004
    - MBAL Sveti Panteleimon
  - Razgrad, Bulgaria, 7200
    - "Medical Center-Razgrad"OOD
  - Razgrad, Bulgaria, 7200
    - Medical Center Re Spiro OOD
  - Sliven, Bulgaria, 8800
    - MBAL Sliven to VMA Sofia
  - Smolyan, Bulgaria, 4700
    - Grigor Lalov
  - Sofia, Bulgaria, 1202
    - SBALPFZ-Sofia district EOOD
  - Stara Zagora, Bulgaria, 6000
    - Prevencia 2000 MCDMP OOD
  - Varna, Bulgaria, 9000
    - Medical Center "Research expert" OOD
  - Veliko Tarnovo, Bulgaria, 5000
    - Medical Center "Tara" OOD
  - Vidin, Bulgaria, 3700
    - MC"Sv.Ivan Rilski"OOD
Czechia
- - Bilina, Czechia, 418 01
    - MUDr. Alena Jelinkova
  - Boskovice, Czechia, 68001
    - MUDr. Eva Krizova
  - Brno, Czechia, 60200
    - Ambulance pro nemoci plicni a TBC, s.r.o.
  - Brno, Czechia, 60200
    - Jana Jančíková
  - Brno, Czechia, 60200
    - MUDr Hana Vašínová
  - Brno, Czechia, 60200
    - MUDr. Ilona Binkova
  - Brno, Czechia, 60200
    - MUDr. Jana Slapnickova s.r.o.
  - Brno, Czechia, 60200
    - MUDr. Jaroslava Lovakova
  - Broumov, Czechia, 55001
    - MUDr. Michal Svarc
  - Ceske Budejovice, Czechia, 370 01
    - MUDr. Jan Faktor Medipont s.r.o.
  - Ceske Budejovice, Czechia, 370 01
    - MUDr. Josef Hlavac Medipont s.r.o.
  - CeskyTesinKonakov, Czechia, 735 62
    - MUDr. Martin Polasek
  - Dobřís, Czechia, 26301
    - MUDr. Jiri Guthwirth
  - Děčín, Czechia, 40502
    - MUDr. Renata Bilkova
  - Frydek-Mistek, Czechia, 738 01
    - MUDr. Martin Adamec Alergonet Group
  - Havlickuv Brod, Czechia, 580 01
    - MUDr. Marie Buresova
  - Holesov, Czechia, 76901
    - MUDr. Jana Psikalova
  - Holesov, Czechia, 76901
    - MUDr. Stanislava Bednarova
  - Hořovice, Czechia, 268 31
    - MUDr. Petr Šafránek
  - Hradec Kralove, Czechia, 500 02
    - MUDr. Hana Lochmanova AXIMED s.r.o.
  - Hranice, Czechia, 753 22
    - MUDr. Ales Bohac Plicni ambulance
  - Hustopece U Brna, Czechia, 693 01
    - MUDr. Lenka Fousova
  - Jihlava, Czechia, 586 01
    - MUDr. Bohumil Kralicek
  - Jihlava, Czechia, 586 01
    - MUDr. Jirina Knillova
  - Jirkov, Czechia, 431 11
    - MUDr. Alexandra Woznicova
  - Kosmonosy, Czechia, 293 06
    - MUDr. Michaela Baerova
  - Kyjov, Czechia, 69701
    - MUDr. Petr Kolman
  - Liberec, Czechia, 460 05
    - MUDr. Milanda Sipkova
  - Louny, Czechia, 44001
    - Plucni Ambulance Louny s.r.o.
  - Miroslav, Czechia, 67172
    - MUDr. Ilona Pavlisova, s.r.o.
  - Mlada Boreslav, Czechia, 29301
    - MUDr. Michaela Baerova
  - Novy Jicin, Czechia, 741 01
    - MUDr. Dusan Velart
  - Novy Jicin, Czechia, 741 01
    - MUDr. Sarka Hofrova
  - Nymburk, Czechia, 288 01
    - MUDr. Sarka Klimesova
  - Náchod, Czechia, 547 01
    - MUDr. Pavla Shihatova
  - Olomouc, Czechia, 779 00
    - MUDr. Ondrej Sobotik
  - Orlová - Lutyně, Czechia, 735 14
    - MUDr. RAdoslav Alexa
  - Ostrava, Czechia, 700 30
    - MUDr. Milena Sramkova
  - Ostrava, Czechia, 70868
    - MUDr. Jana Balounova
  - Ostrava, Czechia, 70868
    - MUDr. Jana Kocianova
  - Ostrava, Bělský Les, Czechia, 700 30
    - Plicní-ambulance Terezie Janásková, s.r.o
  - Pardubice, Czechia, 530 02
    - MUDr. Tereza Dobesova Aximed s.r.o.
  - Pardubice, Czechia, 530 09
    - MUDr. Miluse Zitkova
  - Pelhřimov, Czechia, 396 01
    - MUDr. Jiri Zoula Aries Medici s.r.o.
  - Plzen, Czechia, 301 00
    - MUDr. Petr Hartman
  - Plzen, Czechia, 30100
    - MUDr. Jitka Smolova
  - Plzen, Czechia, 30100
    - MUDr. Vladimir Makrlik
  - Plzen, Czechia, 323 00
    - MUDr. Andrea Svabkova
  - Plzeň, Czechia, 312 00
    - MUDr. Petr Šafránek
  - Poděbrady, Czechia, 290 01
    - MUDr. Jana Janková Zátopková
  - Pohorelice, Czechia, 691 23
    - MUDr. Olga Krizova
  - Praha, Czechia, 120 00
    - MUDr. Fransitek Petrik
  - Praha, Czechia, 16200
    - MUDr. Ivana Jirmanova
  - Praha 1, Czechia, 11000
    - Prvni plicni ambulance s.r.o.
  - Praha 4, Czechia, 14800
    - MUDr. Romana Davidova
  - Praha 5, Czechia, 150 00
    - MUDr. Iva Stachova
  - Praha 5, Czechia, 150 00
    - MUDr. Ivana Zatloukalova
  - Praha 6, Czechia, 161 00
    - MUDr. Milada Typltová
  - Praha 6, Czechia, 169 00
    - MUDr. Jana Jirouskova
  - Praha 6, Czechia, 169 00
    - MUDr. Lenka Povysilova
  - Praha 7, Czechia, 170 00
    - MUDr. Vera Reichmanova
  - Praha 7, Czechia, 17000
    - MUDr. Vera Pacovska
  - Praha 9, Czechia, 19061
    - MUDr. Bronislava Viest
  - Praha 9, Czechia, 19800
    - MUDr. Ivana Boučková
  - Prostejov, Czechia, 79601
    - MUDr. Romana Ivankova
  - Rokycany, Czechia, 33701
    - MUDr. Helena Ringlerova
  - Strakonice, Czechia, 386 01
    - MUDr. Jaroslav Mares
  - Usti nad Labem, Czechia, 400 01
    - MUDr. Alena Kortusova
  - Usti nad Labem, Czechia, 419 01
    - MUDr. Olga Martinkovicova
  - Valasske Mezirici, Czechia, 75701
    - MUDr. Pavel Stach
  - Veselí nad Moravou, Czechia, 69801
    - MUDr. Eva Sabova
  - Zabreh Na Morave, Czechia, 78901
    - MUDr. Pavel Matuska
  - Zidlochovice, Czechia, 667 01
    - MUDr. Alena Prochazkova
  - Čáslav, Czechia, 28601
    - Plicní Čáslav s.r.o.
  - Šumperk, Czechia, 78701
    - MUDr. Margit Hóracková
  - Žamberk, Czechia, 564 01
    - MUDr. Jiri Dolecek
  - Žamberk, Czechia, 56401
    - MUDr. Michal Pasler
Hungary
- - Balassagyarmat, Hungary, 2660
    - Ecce Homo Orvosi Bt.
  - Budapest, Hungary, 1011
    - Dr. Major Katalin IZOPULM Kft.
  - Budapest, Hungary, 1025
    - FOKUSZ-PULMO Egeszsegügyi, Kutatasi, Oktatoi Tanacsado Bt
  - Budapest, Hungary, 1032
    - Kineto-Med Bt.
  - Budapest, Hungary, 1119
    - Dr. Szabó Gyöngyi
  - Budapest, Hungary, 1122
    - Dr. Szilvia Vasas
  - Budapest, Hungary, 1165
    - Emósi Bt.
  - Budapest, Hungary, 1191
    - Főv.XIX.ker.Önk.Egészségügyi Int
  - Budapest, Hungary, 1220
    - Dr. Zoltan Gyula Bende
  - Csitar, Hungary, 2673
    - Fenykepzeles KFT
  - Debrecen, Hungary, 4028
    - Electro-Medic Bt.
  - Debrecen, Hungary, 4028
    - Rizikó '99
  - Dunaújváros, Hungary, 2400
    - Szent Pantaleon Hospital
  - Edelény, Hungary, 3780
    - Pulmo Bt.
  - Eger, Hungary, 3300
    - Dr. Gyetvainé Dr. Lanczki Éva
  - Gyula, Hungary, 5700
    - Broncho-Vin BT.
  - Gyula, Hungary, 5700
    - Pulmoport Kft.
  - Gyöngyössolymos, Hungary, 3231
    - Dr. Kontz Katalin
  - Györ, Hungary, 9021
    - Dr. Szász Zoltán
  - Györ, Hungary, 9023
    - Györ Tüdögondozo
  - Kaposvár, Hungary, 7400
    - Rakvács-Mózes Bt.
  - Komarom, Hungary, 2900
    - Selye János Kórház, Rendelőintézet, Tüdőgondozó
  - Miskolc, Hungary, 3529
    - Borsod-Abaúj-Zemplén Megyei Központ Kórház és Egyetemi Oktatókórház Semmelweis Tagkórház
  - Monok, Hungary, 3905
    - Dr. Bíró Margit
  - Monor, Hungary, 2200
    - Monor Szakrendelö Tüdögondozo
  - Mátészalka, Hungary, 4700
    - Sz.-Sz.-B. MK és EOK. Mátészalka
  - Nagykozár, Hungary, 7741
    - INFER-MED Kft
  - Pécs, Hungary, 7625
    - Dr. Varga Ágnes
  - Pócsmegyer, Hungary, 2017
    - Ujpesti Szakorvosi Rendelöintezet
  - Siofok, Hungary, 8600
    - Dr. Anna Bartha
  - Sopron, Hungary, 9400
    - Dr. Breining és Társa Egészségügyi Szolgáltató Bt.
  - Szeged, Hungary, 6728
    - Dr. Bánvölgyi Aranka Milassinné
  - Szombathely, Hungary, 9700
    - Dr. Geherne Dr. Huszar Hermina Eveline
  - Százhalombatta, Hungary, 2440
    - Dr. Radeczky Éva
  - Vásárosnamény, Hungary, 4800
    - Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
Israel
- - Ashdod, Israel, 77000
    - ASSUTA Ashdod Ltd.
  - Ashkelon, Israel, 78306
    - Barzilai Medical Center
  - Bat Yam, Israel, 5962026
    - Clalit - Bat Yam
  - Beer Sheva, Israel, 85025
    - Soroka Medical Center
  - Hadera, Israel, 38100
    - Hillel Yaffe Medical Center
  - Haifa, Israel, 3436212
    - Carmel Medical Center
  - Holon, Israel, 5810001
    - Edith Wolfson Medical Center
  - Holon, Israel, 5837737
    - Maccabi Healthcare
  - Jerusalem, Israel, 91031
    - Shaarei Zedek Medical Center
  - Jerusalem, Israel, 9112001
    - Research Fund of the Hadassah Medical Organization (R.A.)
  - Jerusalem East, Israel, 9103102
    - Clalit - Jerusalem East
  - Kfar Saba, Israel, 4428164
    - Meir Medical Center Israel
  - Nazareth, Israel, 16234
    - Holy Family Hospital
  - Petach Tikva, Israel, 4941492
    - Rabin Medical Center (Beilinson Hospital)
  - Petach Tikva, Israel, 49473
    - Clalit health services
  - Rehovot, Israel, 76100
    - Kaplan Medical Center
  - Safed, Israel, 13100
    - Health Corporation of the Ziv Medical Center (R.A.)
  - Tel Aviv, Israel, 62098
    - Clalit - Nazareth
  - Tel Aviv, Israel, 62098
    - Clalit - Rishon
  - Tel Aviv, Israel
    - Clalit - Carmiel
  - Tel-Hashomer / Ramat Gan, Israel, 5262000
    - Sheba Medical Center
  - Tiberias, Israel, 15208
    - Poriya Medical Center
  - Zrifin, Israel, 70300
    - Assaf Harofeh MC
Lithuania
- - Kaunas, Lithuania, LT- 50161
    - Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  - Klaipeda, Lithuania, 92231
    - Klaipeda Hospital
  - Klaipėda, Lithuania, 92288
    - Enterprise Klaipeda University Hospital
  - Vilnius, Lithuania, 8661
    - Vilnius University Hospital Santaros Klinikos
  - Vilnius, Lithuania, LT-06122
    - Public Enterprise Vilnius District Central Outpatient Clinic
Poland
- - Biała Podlaska, Poland, 21-500
    - Specjalistyczy Gabinet Lekarski Urszula Świetlik Malesa
  - Białystok, Poland, 15-003
    - ISPL Beata Kuklińska
  - Bochnia, Poland, 32-700
    - Poradnia Chorób Płuc Samodzielny Publiczny Zakład Opieki Zdrowotnej"Szpital Powiatowy"W Bochni
  - Bydgoszcz, Poland, 85-324
    - Indywidualna Praktyka Lekarska Aleksandra Burysz
  - Bydgoszcz, Poland, 85-915
    - Specjalistyczna Praktyka Lekarska Choroby Płuc Agata Kalicka
  - Chorzów, Poland, 41-500
    - Indywidualna Specjalistyczna Praktyka Lekarska Dr. n. med. Szymon Dworniczak
  - Ciecierzyn, Poland, 21-003
    - Indywidualna Specjalistyczna Praktyka Lekarska Anna Góra-Florek
  - Gdynia, Poland, 81-363
    - ODM Gdynia
  - Jasło, Poland, 38-200
    - Specjalistyczna Praktyka Lekarska i USG
  - Jelenia Góra, Poland, 58-500
    - Specjalistyczny Gabinet Lekarski Juliusz Bokiej
  - Kielce, Poland, 25-528
    - Niepubliczny Zakład Opieki Specjalistycznej "Zdrowe Płuca"
  - Kielce, Poland, 25-751
    - Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis
  - Koszalin, Poland, 75-252
    - Specjalistyczny Zespół Gruźlicy i chorób Płuc
  - Końskie, Poland, 26-200
    - Gabinet lekarski Renata Pejas-Dulewicz
  - Kościan, Poland, 64000
    - Gabinet lekarski Wojciech Machowiak
  - Kraków, Poland, 30-901
    - Poradnia Chorób płuc
  - Kraków, Poland, 31-443
    - Indywidualna Praktyka Lekarska Aleksander Kania
  - Kraków, Poland, 31-619
    - Gabinet lekarski Thomasz Mysior
  - Kłomnice, Poland, 42-270
    - Lekarskie Wizyty Domowe Jarosław Zięba
  - Lublin, Poland, 20-086
    - Specjalistyczna Praktyka Lekarska Piotr Kamiński
  - Lublin, Poland, 20-089
    - Alergopneuma sp. Z.o.o.
  - Olmonty, Poland, 15-603
    - ISPL Łukasz Minarowski
  - Parczew, Poland, 21-200
    - Prywatny gabinet lakarski Izabela Piętowska-Łazuka
  - Piaseczno, Poland, 05-500
    - Medycyna-diagnostyka Adam Nowiński
  - Poznań, Poland, 60-313
    - MEDICAL-MED. Indywidualna Specjalistyczna Praktyka Lekarska Barbara Kuźnar-Kamińska
  - Poznań, Poland, 60-750
    - Indywidualna Specjalistyczna Praktyka Lekarska Magdalena Kostrzewska
  - Proszowice, Poland, 32-100
    - Poradnia Gruźlicy i Chorób Płuc SPZOZ Proszowice
  - Pyskowice, Poland, 44-120
    - Gabinet lekarski Roman Masarczyk
  - Płock, Poland, 09-408
    - Gabinet lekarski Edyta Kozińska
  - Racibórz, Poland, 47-400
    - Szpital Rejonowy im.dr Rostka-Oddził Pulmonologiczny
  - Rzeszów, Poland, 35-241
    - Podkarpackie Centrum Chorób Płuc
  - Sieradz, Poland, 98-200
    - Gabinet lekarski Choroby płuc i oskrzeli Joanna Tęsiorowska
  - Sosnowiec, Poland, 41-200
    - Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Filipek
  - Słupsk, Poland, 76-200
    - NZOZ Poradnia Chorób Płuc i Alergologii
  - Tarnobrzeg, Poland, 39-400
    - NZOZ Centrum Medyczne SBB
  - Trzebnica, Poland, 55-100
    - Viltis Medica Spejalistyczan Praktyla Lekarska lek.med. Agata Kot
  - Warsaw, Poland, 02-507
    - MSWiA
  - Warszawa, Poland, 00-201
    - STANMED Gabinet Lekarski Robert Staniszewski
  - Warszawa, Poland, 01-164
    - Instytut Gruźlicy i Chorób Płuc
  - Warszawa, Poland, 01-631
    - Gabinet lekarski Beata Żołnowska
  - Warszawa, Poland, 03-984
    - Wizyty Domowe Internisty B. Homola-Piekarska
  - Warszawa, Poland, 04-907
    - Gabinet lekarski Andrzej Jaworski
  - Wieruszów, Poland, 98-400
    - Gabinet Internistyczny-Choroby płuc lek.med.M.Kraszewska
  - Wroclaw, Poland, 51-664
    - Specjalistyczna Praktyka Lekarska dr n.med. Andrzej Obojski
  - Zakopane, Poland, 34-500
    - Specjalistyczny Szpital Chorób Płuc Odrodzenie im Klary Jelskiej
  - Łódź, Poland, 90-153
    - Uniwersytecki Szpital Kliniczny Nr 1
  - Łódź, Poland, 91-520
    - Centrum Leczenia Chorób Płuc w Łodzi
  - Łódź, Poland, 93-219
    - Przychodnia Specjalistyczna Snzoz Med Med. Sp.Z O.O
Romania
- - Arad, Romania, 315200
    - DaniPneumoMed SRL
  - Bacau, Romania, 600148
    - Butacel F. Maria Danisia - Medic Specialist Pneumolog
  - Bistrița, Romania, 420080
    - Manolache Cristina - Medic Specialist Pneumologie
  - Botoșani, Romania, 710336
    - Dr. Bendas Magdalena
  - Brasov, Romania, 500295
    - Muresan Alina Pneumoconsult Srl
  - Bucharest, Romania, 61191
    - Borcea Corina-Ioana Persoana Fizica Autorizata
  - Bucuresti, Romania, 31746
    - Dr Cosei Valentin-Caius Pfi
  - București, Romania, 61593
    - Ispas Elena-Irina Medic Specialist Pneumolog
  - Constanta, Romania, 900621
    - Pneumo Clinic Care SRL
  - Craiova, Romania, 200501
    - Crm Pneumology Srl
  - Craiova, Romania, 200677
    - Nicolosu Med Srl
  - Focsani, Romania, 620003
    - Avencord SRL
  - Iasi, Romania, 700233
    - Miron V. Ramona - Medic Colaborator
  - Jud Constanta, Romania, 38079525
    - Howas Med Srl
  - Jud. Cluj, Mun. Cluj-Napoca, Romania, 400414
    - Ciumarnean G Lorena Medic Specialist
  - Jud. Cluj, Mun. Cluj-Napoca, Romania, 400426
    - Chis P Ana Florica - Medic Specialist Pneumologie
  - Jud. Giurgiu , Mun. Giurgiu, Romania, 80121
    - Cabinet Medical Individual Defta I. Doina-Elisabeta
  - Milcovul, Romania, 30167
    - Rarcolmed Srl
  - Mun. Târgu Jiu, Romania, 210164
    - Vlad M. Elena - Medic Primar Pneumolog
  - Piatra Neamt, Romania, 610255
    - Medic Primar Pneumologie Stoleru Manuela
  - Popesti Leordeni, Romania, 77160
    - Raissa Maria Medical Srl
  - Ramnicu-Sarat, Romania, 5273
    - PFI Chirea C. Monica Valentina
  - Râmnicu Vâlcea, Romania, 167473
    - Viosan-Resp S.R.L.
  - Sat Ariniș, Romania, 437010
    - Jager Pneumo Services Srl
  - Sat Visan, Jud Iasi, Romania, 700285
    - Sc Nexus Medical Srl
  - Tg.Lăpuș, Romania, 435600
    - Cabinet Medical Individual Dr. Butuc Lilia
  - Timisoara, Romania, 300587
    - Cabinet Medical Pneumologie Dr. Albu Claudia
  - Vanju Mare, Romania, 225400
    - CMI Dr. Mihailescu Constantin
Russian Federation
- - Angarsk, Russian Federation, 665831
    - Treatment and consultation center
  - Astrakhan, Russian Federation, 414018
    - Volga district hospital
  - Astrakhan, Russian Federation, 414056
    - Alexander Mariinsky regional clinical hospital
  - Barnaul, Russian Federation, 656000
    - Departmental clinical hospital on the station Barnaul of OJSC "RZhD"
  - Barnaul, Russian Federation, 656045
    - Barnaul city hospital Nr.5
  - Belgorod, Russian Federation, 308015
    - Out-patient hospital "Harmony of health"
  - Bryansk, Russian Federation, 214028
    - Bryansk Regional Hospital No. 1
  - Checkov 2, Russian Federation, 142302
    - Chekhov central district out-patient hospital
  - Chelyabinsk, Russian Federation, 454076
    - Chelyabinsk Regional Clinical Hospital
  - Chelyabinsk, Russian Federation, 454091
    - Road clinical hospital at station Chelyabinsk RRR
  - Chelyabinsk, Russian Federation, 454106
    - LLC "AllergoStop", Center of asthma prophylactic and treatment of allergy and asthma
  - Chelyabinsk, Russian Federation, 454106
    - Regional Clinical Hospital Nr.3
  - Chelyabinsk, Russian Federation, 454219
    - Institution of public health City clinical hospital #11
  - Ekaterinburg, Russian Federation, 320109
    - LLC Medical unity "Novaya Bolnitsa
  - Ekaterinburg, Russian Federation, 620000
    - Sverdlovsk regional hospital Nr. 2
  - Ekaterinburg, Russian Federation, 620026
    - Central city clinical hospital No. 1 of Oktyabrsky district
  - Ekaterinburg, Russian Federation, 620039
    - City clinical hospital No. 14
  - Ekaterinburg, Russian Federation, 620067
    - Central clinical hospital Nr. 3
  - Ekaterinburg, Russian Federation, 620109
    - Medical Association "Novaya Bolnitsa" Polyclinic
  - Ekaterinburg, Russian Federation, 620137
    - Central City Hospital Nr.7
  - Irkutsk, Russian Federation, 644032
    - Regional Oncology Dispensary
  - Irkutsk, Russian Federation, 664046
    - Irkutsk state clinical hospital Nr.1
  - Irkutsk, Russian Federation, 665827
    - East and Siberian institute of medical and ecological studies
  - Iskitim, Russian Federation, 633000
    - LLC Pulsar
  - Ivanovo, Russian Federation, 153005
    - City Clinical Hospital No. 4
  - Kaluga, Russian Federation, 248007
    - Kaluga Regional Clinical Hospital
  - Kazan, Russian Federation, 420036
    - LLC "City Clinical hospital #12"
  - Kazan, Russian Federation, 420059
    - Medical Association "Spasenie"
  - Kazan, Russian Federation, 420064
    - City clinical hospital Nr. 16
  - Kazan, Russian Federation, 420064
    - State autonomy institution of public health
  - Kemerovo, Russian Federation, 650036
    - Kemerovo regional clinical phthisiopulmonology medical center
  - Kemerovo, Russian Federation, 650993
    - Regional clinical hospital of emergency medical care named after M.A. Podgorbunsky
  - Kirov, Russian Federation, 610000
    - LLC "Doctor Lite"
  - Kirov, Russian Federation, 610050
    - Kirov clinical and diagnostic centeron the basis of out-patient hospital Nr. 1
  - Krasnodar, Russian Federation, 350086
    - Krai clinical hospital Nr. 1 named after prof. S.V. Ochapovskogo
  - Krasnoyarsk, Russian Federation, 660022
    - Krai Clinical Hospital
  - Krasnoyarsk, Russian Federation, 661123
    - Krasnoyarsk inter-district clinical hospital Nr. 20 named after I.S. Berzon
  - Kurgan, Russian Federation, 640000
    - Kurgan out-patient hospital
  - Kurgan, Russian Federation, 640000
    - Kurgan regional clinical hospital
  - Kursk, Russian Federation, 305004
    - Out-patient hospital of regional budgetary institution of public health
  - Kursk, Russian Federation, 306900
    - Medassist-K
  - Lipetsk, Russian Federation, 398046
    - Lipetsk city out-patient hospital Nr. 7
  - Makhachkala, Russian Federation, 367000
    - Republican clinical hospital of war and labor veterans
  - Moscow, Russian Federation, 117449
    - City out-patient hospital Nr. 22 of department of public health of Moscow, branch Nr. 2
  - Moscow, Russian Federation, 117463
    - City out-patient hospital Nr. 134 of department of public health of Moscow
  - Moscow, Russian Federation, 117546
    - City out-patient hospital Nr. 52 of department of public health of Moscow
  - Moscow, Russian Federation, 119991
    - First Moscow State Medical University named after I. M. Sechenov
  - Moscow, Russian Federation, 125222
    - Institution of public health "City out-patient hospital #180 of department of public health of Moscow
  - Moscow, Russian Federation, 127540
    - Consultation and diagnostic center Nr. 6 of department of public health of Moscow
  - Moscow, Russian Federation, 129110
    - Moscow Regional Research Clinical Institute named after M.F. Vladimirsky
  - Moskau, Russian Federation, 105077
    - Educational institution of higher education named after N.I. Pirogov of Ministry of health of Russia
  - Moskau, Russian Federation, 105077
    - Moscow scientific and clinical educational center for respiratory medicine
  - Nizhnevartovsk, Russian Federation, 628624
    - Nizhnevartovsk county hospital No.2
  - Nizhny Novgorod, Russian Federation, 603005
    - Nizhny Novgorod scientific and research institute of sanitary science and occupational pathology
  - Nizhny Novgorod, Russian Federation, 603005
    - Privolzhsky Research Medical University
  - Nizhny Novgorod, Russian Federation, 603093
    - Nizhny Novgorod city clinical hospital named after N.A. Semashko
  - Novokuznetsk, Russian Federation, 654038
    - Novokuznetsk city clinical hospital Nr. 29
  - Novosibirsk, Russian Federation, 360000
    - Azbuka zdoroviya
  - Novosibirsk, Russian Federation, 360003
    - Road clinical hospital on station Novosibirsk-Main of OJSC "RZhD"
  - Novosibirsk, Russian Federation, 360051
    - City Clinical Hospital No. 2
  - Novosibirsk, Russian Federation, 630099
    - Zdorovaya Semiya
  - Novosibirsk, Russian Federation, 630117
    - Scientific and research institute of physiology and fundamental medicine
  - Novovsibirsk, Russian Federation, 630099
    - City clinical out-patient hospital No. 1
  - Omsk, Russian Federation, 644000
    - Clinical medical sanitary station Nr. 7
  - Omsk, Russian Federation, 644009
    - City out-patient hospital No. 2
  - Omsk, Russian Federation, 644024
    - Multifunctional center of modern medicine "Evromed"
  - Omsk, Russian Federation, 644033
    - ZAO "Multifunctional center of modern medicine "Evromed"
  - Orel, Russian Federation, 302000
    - City hospital named after S. P. Botkin
  - Orenburg, Russian Federation, 460000
    - Orenburg regional clinical hospital No. 2
  - Penza, Russian Federation, 440026
    - Penza Regional Clinical Hospital named after N.N. Burdenko
  - Penza, Russian Federation, 440071
    - Clinical hospital No. 6 named after G.A. Zakhariyn
  - Perm, Russian Federation, 614000
    - City clinical out-patient hospital of Perm
  - Perm, Russian Federation, 614038
    - Perm clinical center of federal medical and biological agency "Medical sanitary station #140" on the basis of out-patient hospital #2
  - Perm, Russian Federation, 614066
    - City clinical out-patient hospital #2
  - Perm, Russian Federation, 614070
    - "City out-patient hospital #7" on the basis of out-patient hospital #2
  - Perm, Russian Federation, 614097
    - City clinical out-patient hospital No. 4
  - Perm, Russian Federation, 614990
    - Perm Regional Clinical Hospital
  - Petrozavodsk, Russian Federation, 185007
    - Hospital of Karelia republic named after V.A.Baranov
  - Podolsk, Russian Federation, 142110
    - 1586 military clinical hospital of Ministri of Public Defense
  - Pyatigorsk, Russian Federation, 357500
    - Treatment and prophylactic institution of union health resort "Rodnik"
  - Rostov-on-Don, Russian Federation, 344011
    - Clinical and diagnostic center "Zdorovie" of Rostov-on-Don
  - Rostov-on-Don, Russian Federation, 344015
    - Rostov regional clinical hospital
  - Rostov-on-Don, Russian Federation, 344091
    - City clinical hospital No. 20 of Rostov-on-Don"
  - Ryazan, Russian Federation, 390039
    - Regional Clinical Hospital
  - Ryazan, Russian Federation, 390026
    - Regional clinical cardiology dispensary
  - Saint Petersburg, Russian Federation, 193312
    - Aleksandrovskaya City Hospitel
  - Saint-Petersburg, Russian Federation, 191025
    - ZAO "Medi"
  - Saint-Petersburg, Russian Federation, 191952
    - LLC "Medical center XXI century" Bryanseva 13"
  - Saint-Petersburg, Russian Federation, 197022
    - First Saint-Petersburg state medical university named after acad. I.P.Pavlov
  - Samara, Russian Federation, 443000
    - Samara city out-patient hospital No.1
  - Samara, Russian Federation, 443051
    - Samara medical and sanitary unit Nr. 5 of the Kirovsky district
  - Samara, Russian Federation, 443056
    - City clinical hospital Nr 4 of Samara
  - Samara, Russian Federation, 443069
    - Samara city hospital Nr. 13 of Zheleznodorozhny district
  - Samara, Russian Federation, 443111
    - Samara city clinical out-patient hospital No.15
  - Sankt Petersburg, Russian Federation, 194354
    - City Consultative and Diagnostic Centre Nr. 1
  - Saransk, Russian Federation, 430005
    - National Mordovia research state university named after N.P. Ogarev
  - Saratov, Russian Federation, 410033
    - Saratov city out-patient hospital Nr. 9
  - Saratov, Russian Federation, 410052
    - Saratov city clinical hospital No. 8
  - Saratov, Russian Federation, 410053
    - Saratov city out-patient hospital Nr. 10
  - Simferopol, Russian Federation, 295024
    - Simferopol city clinical hospital Nr. 7
  - Simferopol, Russian Federation, 950000
    - Simferopol clinical hospital
  - Smolensk, Russian Federation, 214000
    - Out-patient hospital #5
  - Smolensk, Russian Federation, 214012
    - Clinical hospital No. 1
  - St. Petersburg, Russian Federation, 196084
    - Institute of Medical Trials
  - Stavropol, Russian Federation, 355030
    - Stavropol krai clinical hospital
  - Tambov, Russian Federation, 392000
    - Tambov regional clinical hospital named after V.D. Babenko
  - Tolyatti, Russian Federation, 445039
    - Tolyatti city hospital Nr. 5
  - Tomsk, Russian Federation, 634063
    - Tomsk Regional Clinical Hospital
  - Tomsk, Russian Federation, 634012
    - Treatment and diagnostic center
  - Tomsk, Russian Federation, 634050
    - Out-patient hospital No. 1
  - Tomsk, Russian Federation, 636037
    - Federal state budgetary institution of SibFNKC FMBA of Russia
  - Tula, Russian Federation, 300002
    - City hospital Nr. 9
  - Tver, Russian Federation, 170036
    - Regional Clinical Hospital
  - Tyumen, Russian Federation, 625017
    - Regional hospital No. 19 Out-patient hospital
  - Ufa, Russian Federation, 450071
    - City clinical hospital Nr. 21
  - Ufa, Russian Federation, 450071
    - Republican Clinical Hospital named after G.G. Kuvatov
  - Vladimir, Russian Federation, 600023
    - Vladimir Regional clinical hospital
  - Volgograd, Russian Federation, 400081
    - Volgograd regional clinical hospital Nr. 1
  - Volgograd, Russian Federation, 400120
    - Non-state institution of public health Divisional clinical hospital on station Volgograd-1 of OJSC "RZhD"
  - Voronezh, Russian Federation, 394018
    - Institution of public health of Voronezh region "Voronezh regional clinical consultation and diagnostic center"
  - Voronezh, Russian Federation, 394026
    - LLC medical center "Diagnostic plus"
  - Yaroslavl, Russian Federation, 150062
    - Institution of public health of Yaroslavl region Regional clinical hospital
Slovenia
- - Celje, Slovenia, 3000
    - Internistična ambulanta za pljučne in alergijske bolezni Karmen Kramer Vrščaj
  - Kamnik, Slovenia, 1241
    - Pulmološka ambulanta dr. Snežana Ulčar Kostič s.p.
  - Kočevje, Slovenia, 1330
    - MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.
  - Kranj, Slovenia, 4000
    - VELOG, Zdravstveni center, d.o.o.
  - Kranj, Slovenia, 4000
    - Zdravstvene storitve in svetovanje, Tjaša Šubic s.p.
  - Litija, Slovenia, 1270
    - Verboten Kopriva Renata - Ordinacija Interne Medicine
  - Ljubljana, Slovenia, 1000
    - Arjana Maček d.o.o
  - Ljubljana, Slovenia, 1000
    - Kambič-Kafol d.o.o.
  - Ljubljana, Slovenia, 1000
    - Medvital Katarina Vukelič s.p.
  - Maribor, Slovenia, 2000
    - Alveola, internistični ambulantni diagnostični center d.o.o.
  - Maribor, Slovenia, 2000
    - CIIM PLUS, center za interno in interventno medicino, d.o.o.
  - Maribor, Slovenia, 2000
    - INTERNIST MB - specialistična ambulantna dejavnost, Marko Bombek s.p.
  - Maribor, Slovenia, 2000
    - Zdravstveno svetovanje in storitve, Krstić Zoran, s.p.
  - Murska Sobota, Slovenia, 9000
    - Mag. Anton Lopert, dr.med. - Zasebna internistična ambulanta
  - Murska Sobota, Slovenia, 9000
    - Zasebna ambulanta za pljučne bolezni, mag. Alojz Horvat, dr. med.
  - Velenje, Slovenia, 3320
    - Dr. Ana Novakovic
  - Velenje, Slovenia, 3320
    - Dr. med. Tomaz Smonkar
  - Velenje, Slovenia, 3320
    - Dr. Mikro Lekic
  - Škofja vas, Slovenia, 3211
    - Prim. mag. Šegota Nikša, dr.med., specialistična zdravniška dejavnost, s.p.
Switzerland
- - Basel, Switzerland, 4051
    - Gruppenpraxis Basel
  - Frick, Switzerland, 5070
    - Gruppenpraxis Frick
  - Geuensee, Switzerland, 6232
    - Gruppenpraxis Emmenbrücke
  - Heiligenschwendi, Switzerland, 3625
    - Berner Reha Zentrum Medizin Pneumologie
  - Luzern, Switzerland, 6004
    - Gruppenpraxis Luzern
  - Utznach, Switzerland, 8730
    - Spital Linth
  - Wald, Switzerland, 8636
    - Zürcher RehaZentrum Wald
Ukraine
- - Dnipropetrovsk, Ukraine, 49074
    - Dnipropetrovsk 6 City clinical Hospital
  - Ivano-Frankivsk, Ukraine, 76018
    - Regional centre of Phtysiology and Pulmonology
  - Kharkiv, Ukraine, 61001
    - City Clinical Hospital Nr. 13
  - Kyiv, Ukraine, 3038
    - National Institute of Phthisiology and Pulmonology named F. G. Yanovsky National Academy of Medical Sciences of Ukraine
  - Lutsk, Ukraine, 43000
    - Volyn Regional Clinical Hospital
  - Lviv, Ukraine, 79000
    - Lviv Regional Phthisiopneumological Clinical Treatment and Diagnostic Center
  - Vinnitsa, Ukraine, 21029
    - Vinnytsia City Clinical Hospital Nr. 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Around 4500 COPD patients from approximately 11 countries will be collected, with a signed informed consent will be maintained in the ISF at the investigational site irrespective of whether they have been treated or not.

Description

Inclusion Criteria:

Written informed consent prior to participation
Female and male patients ≥40 years of age
Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines

Exclusion Criteria:

Patients with contraindications according to Spiolto® Respimat® SmPC
Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
Pregnancy and lactation
Current participation in any clinical trial or any other non-interventional study of a drug or device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort Group / Cohort A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.	Intervention / Treatment Intervention / Treatment A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
subjects with COPD	Drug: Spiolto® Respimat® Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 Time Frame: At Visit 2 (6 weeks after baseline visit 1)	Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.	At Visit 2 (6 weeks after baseline visit 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) Time Frame: At visit 1	PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).	At visit 1
Physician's Global Evaluation (PGE) Score at Visit 2 Time Frame: At visit 2 (6 weeks after baseline visit 1)	PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).	At visit 2 (6 weeks after baseline visit 1)
Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 Time Frame: At baseline visit 1 and 6 weeks thereafter at visit 2	The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.	At baseline visit 1 and 6 weeks thereafter at visit 2
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 Time Frame: At visit 2 (6 weeks after baseline visit 1)	Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.	At visit 2 (6 weeks after baseline visit 1)
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 Time Frame: At visit 2 (6 weeks after baseline visit 1)	Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported	At visit 2 (6 weeks after baseline visit 1)
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 Time Frame: At visit 2 (6 weeks after baseline visit 1)	Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.	At visit 2 (6 weeks after baseline visit 1)
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 Time Frame: At visit 2 (6 weeks after baseline visit 1)	Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.	At visit 2 (6 weeks after baseline visit 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

Study Chair: Alexey Medvedchikov, +431801057896, alexey.medvedchikov@boehringer-ingelheim.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

October 4, 2019

Study Completion (Actual)

October 4, 2019

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

1237-0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studiesin products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:

find information in order to request access to clinical study data, for listed studies.
request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Spiolto® Respimat®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations